Oncolytics Biotech reported that in the GOBLET Phase 1/2 study, 30 % of patients with ≥2L metastatic squamous cell anal carcinoma achieved objective responses to pelareorep in combination with atezolizumab (Tecentriq®).
The 30 % objective response rate was based on six responses among 20 evaluable patients, including two durable complete responses—one ongoing beyond two years and another lasting 15 months—and a third response lasting 64 weeks.
Median duration of response was 15.5 months for the pelareorep‑atezolizumab combination versus 9.5 months for standard of care.
The study, conducted at 17 centers in Germany and managed by AIO‑Studien‑gGmbH, is a Phase 1/2 multiple‑indication study.
Oncolytics plans to discuss a single‑arm accelerated‑approval study with the FDA in the first half of 2026.
Pelareorep, an intravenous double‑stranded RNA immunotherapeutic, has Fast Track designation for metastatic breast cancer and advanced pancreatic cancer and orphan drug status for pancreatic cancer.
The company highlighted the results as the most encouraging efficacy signal with a non‑chemo regimen in anal cancer and is seeking strategic partnerships to accelerate development.
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